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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022519

DUEXIS (FAMOTIDINE; IBUPROFEN)
26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FAMOTIDINE; IBUPROFEN
Proprietary Name: DUEXIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022519
Product Number: 001
Approval Date: Apr 23, 2011
Applicant Holder Full Name: HORIZON MEDICINES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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